Y-mAbs Shifts Focus To Approved Drug, Pipeline After Omburtamab CRL
The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.
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Finance Watch: Sun Shines On Biotech Stocks As J.P. Morgan Ends
Public Company Edition: Also, Johnson & Johnson’s consumer health spin-out Kenvue filed paperwork to get the ball rolling on an initial public offering. In addition, Geron raised $198m and Madrigal accessed more than $300m after positive trial readouts, but layoffs were revealed by Editas, Elevation, Nabriva and others.
ODAC Applauds Effort, But Votes Against Y-mAbs’ I-Omburtamab In Neuroblastoma
US FDA advisory committee voted unanimously that there was not enough evidence to show the monoclonal antibody improves overall survival, but panelists are hopeful that real-world evidence could eventually get the orphan candidate over the finish line.
Y-mAbs Gives Thanks For First Approved Drug Danyelza
US regulators refused to accept the file for one of Y-mAbs's neuroblasoma drugs – omburtamab – in October but have given the green light to a second one, naxitamab.